Abstract
Paediatric oncology is a classic example of a field in which research and care are closely intertwined. Moreover, bioethicists have argued that in environments such as paediatric oncology we should no longer draw sharp distinctions between research and care. Recently, two Dutch protocols for the treatment of children with Acute Lymphoblastic Leukaemia (ALL) have been categorised in two different ways, one as research (ALL-11) and the other as treatment (ALL-10). We analysed these protocols in order to explore whether the distinction between research and care in paediatric oncology is morally relevant. We applied several characteristics of research to the ALL-10 and 11 protocols: the goal of producing generalisable knowledge; systematic collection of data; potentially high and uncertain risks; burdens and risks unrelated to treatment; and provision of treatment according to detailed protocols. Both ALL-protocols exhibit general characteristics of research. At the same time, both protocols also clearly satisfy the objective of delivering the best available treatment. Therefore, it remains to be discussed how to review these kinds of protocols that integrate a research goal with the objective of providing individual patients with best current treatment. A change in both research ethics regulation and oversight of conventional care is needed. More case studies are essential to expand the moral evaluation of the intertwinement between research and care in paediatric oncology.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Ablett, S., and C.R. Pinkerton. 2003. Recruiting children into cancer trials—role of the United Kingdom Children’s Cancer Study Group (UKCCSG). British Journal of Cancer 88: 1661–1665.
American Academy of Pediatrics (AAP). 1995. Informed consent, parental permission, and assent in pediatric practice. Pediatrics 95: 314–317.
Beauchamp, T.L. 2011. Viewpoint: Why our conceptions of research and practice may not serve the best interest of patients and subjects. Journal of Internal Medicine 269: 383–387.
Bleyer, W.A. 1997. The U.S. pediatric cancer clinical trials programmes: International implications and the way forward. European Journal of Cancer 33: 1439–1447.
Brody, H., and F.G. Miller. 2003. The clinician-investigator. Unavoidable but manageable tension. Kennedy Institute of Ethics Journal 13: 329–346.
Conroy, S., C. Newman, and S. Gudka. 2003. Unlicensed and off label drug use in acute lymphoblastic leukaemia and other malignancies in children. Annals of Oncology 14: 42–47.
Council for International Organizations of Medical Sciences (CIOMS). 2002. International ethical guidelines for biomedical research involving human subjects. Geneva.
Council of Europe (CoE). 2005. Additional protocol to the convention on human rights and biomedicine, concerning biomedical research. Strasbourg.
de Vries, M.C., M. Houtlosser, J.M. Wit, D.P. Engberts, D. Bresters, G.J. Kaspers, and E. van Leeuwen. 2011. Ethical issues at the interface of clinical care and research practice in pediatric oncology: A narrative review of parents’ and physicians’ experiences. BMC Medical Ethics 12: 18.
European Parliament (EP). Directive 2001/20/EC of the European Parliament and of the Council (Apr 4 2001).
European Parliament (EP). Regulation (EC) No 1901/2006 of the European Parliament and of the Council (Dec 12, 2006).
European Parliament (EP). Regulation (EU) No 536/2014 of the European Parliament and of the Council (Apr 16, 2014).
Grady, C. 1991. Ethical issues in clinical trials. Seminars in Oncology Nursing 7: 288–296.
Gupta, T., S. Kannan, V. Dantkale, and S. Laskar. 2011. Cyclophosphamide plus total body irradiation compared with busulfan plus cyclophosphamide as a conditioning regimen prior to hematopoietic stem cell transplantation in patients with leukemia: A systematic review and meta-analysis. Hematology/Oncology and Stem Cell Therapy 4: 17–29.
Joffe, S., and J.C. Weeks. 2002. Views of American oncologists about the purposes of clinical trials. Journal of the National Cancer Institute 94: 1847–1853.
Kass, N.E., R.R. Faden, S.N. Goodman, P. Pronovost, S. Tunis, and T.L. Beauchamp. 2013. The research-treatment distinction: A problematic approach for determining which activities should have ethical oversight. The Hastings Center Report 43(s1): S4–S15.
Kimland, E., P. Nydert, V. Odlind, Y. Bottiger, and S. Lindemalm. 2012. Paediatric drug use with focus on off-label prescriptions at Swedish hospitals – A nationwide study. Acta Paediatrica 101: 772–778.
Krueger, G. 2008. Hope and suffering children, cancer and the paradox of experimental medicine. Baltimore: Johns Hopkins University Press.
Largent, E.A., S. Joffe, and F.G. Miller. 2011. Can research and care be ethically integrated? The Hastings Center Report 41: 37–46.
Lindell-Osuagwu, L., M.J. Korhonen, S. Saano, M. Helin-Tanninen, T. Naaranlahti, and H. Kokki. 2009. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. Journal of Clinical Pharmacy and Therapeutics 34: 277–287.
Linsenmeier, C., D. Thoennessen, L. Negretti, J.P. Bourquin, T. Streller, U.M. Lutolf, et al. 2010. Total body irradiation (TBI) in pediatric patients. A single-center experience after 30 years of low-dose rate irradiation. Strahlentherapie und Onkologie 186: 614–620.
Nachman, J.B., H.N. Sather, M.G. Sensel, M.E. Trigg, J.M. Cherlow, J.N. Lukens, et al. 1998. Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy. New England Journal of Medicine 338: 1663–1671.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR). 1979. The Belmont Report. Ethical principles and guidelines for the protection of human subjects. Department of Health, Education, and Welfare.
Pandolfini, C., and M. Bonati. 2005. A literature review on off-label drug use in children. European Journal of Pediatrics 164: 552–558.
Peeters, M., and A. Poon. 1987. Down syndrome and leukemia: Unusual clinical aspects and unexpected methotrexate sensitivity. European Journal of Pediatrics 146: 416–422.
Pieters, R. 2010. Acute lymphoblastic leukaemia in children and adolescents: Chance of cure now higher than 80 %. Nederlands Tijdschrift voor Geneeskunde 154: A1577.
Stichting Kinderoncologie Nederland (SKION) Richtlijn follow-up na kinderkanker. SKION; 2010.
Stiller C. 2009. Incidence of childhood leukaemia. World Health Organization Europe.
Szczepanski, T., A. Orfao, V.H. van der Velden, J.F. San Miguel, and J.J. van Dongen. 2001. Minimal residual disease in leukaemia patients. The Lancet Oncology 2: 409–417.
‘t Jong, G.W., A.G. Vulto, M. de Hoog, K.J. Schimmel, D. Tibboel, and J.N. van den Anker. 2000. Unapproved and off-label use of drugs in a children’s hospital. New England Journal of Medicine 343: 1125.
van den Berg, H., and N. Tak. 2011. Licensing and labelling of drugs in a paediatric oncology ward. British Journal of Clinical Pharmacology 72: 474–481.
van Dongen, J.J., T. Seriu, E.R. Panzer-Grumayer, A. Biondi, M.J. Pongers-Willemse, L. Corral, et al. 1998. Prognostic value of minimal residual disease in acute lymphoblastic leukaemia in childhood. Lancet 352: 1731–1738.
van Thiel, G.J.M.W., and J.J.M. van Delden. 2010. Reflective equilibrium as a normative empirical model. Ethical Perspectives 17: 183–202.
Verschuur, A.C. 2004. De plaats van klinische trials in de kinderoncologie. Ned Tijdschr Oncol 1(1): 30–33.
Weijer, C., and P.B. Miller. 2003. Therapeutic obligation in clinical research. The Hastings Center Report 33: 19–28.
Whitlock, J.A. 2006. ∁. British Journal of Haematology 135: 595–602.
WMO Medical Research involving Human Beings Act (Mar 1, 2006).
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Dekking, S.A.S., van der Graaf, R., de Vries, M.C., Bierings, M.B., van Delden, J.J.M. (2016). Discriminating Between Research and Care in Paediatric Oncology—Ethical Appraisal of the ALL-10 and 11 Protocols of the Dutch Childhood Oncology Group (DCOG). In: Strech, D., Mertz, M. (eds) Ethics and Governance of Biomedical Research. Research Ethics Forum, vol 4. Springer, Cham. https://doi.org/10.1007/978-3-319-28731-7_5
Download citation
DOI: https://doi.org/10.1007/978-3-319-28731-7_5
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-28729-4
Online ISBN: 978-3-319-28731-7
eBook Packages: Religion and PhilosophyPhilosophy and Religion (R0)